NCT07353554

Brief Summary

This study intends to employ 68Ga-NOTA-BCMA nanobody PET/CT imaging in patients with multiple myeloma to evaluate the feasibility of this technique for myeloma assessment, analyze the correlation between 68Ga-NOTA-BCMA nanobody uptake intensity and disease staging, tumor burden, and prognosis, explore its value in assessing treatment response and predicting early relapse, and compare its detection rate for myeloma lesions with that of 18F-FDG PET/CT. The results of this study may provide a more sensitive and specific imaging diagnostic method for patients with multiple myeloma and offer a basis for the individualized selection of future BCMA-targeted therapies. This study has been approved by the Ethics Committee of Peking Union Medical College Hospital.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
21mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Feb 2026Feb 2028

First Submitted

Initial submission to the registry

September 10, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

January 20, 2026

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 10, 2025

Last Update Submit

January 18, 2026

Conditions

Multiple Myeloma (MM)

Keywords

Multiple MyelomaPET/CTBCMA

Outcome Measures

Primary Outcomes (1)

  • Detection rate of 68Ga-BCMA nanobody PET/CT

    The number of patients with positive BCMA PET results was counted and divided by the total number of individuals who completed BCMA PET imaging to calculate the detection rate of BCMA PET.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Survival

    through study completion, an average of 1 year

Study Arms (1)

BCMA and FDG

EXPERIMENTAL

All enrolled patients will undergo both 68Ga-BCMA nanobody PET/CT imaging and 18F-FDG PET/CT imaging.On the day of the examination (fasting is not required), an intravenous injection of the 68Ga-NOTA-BCMA nanobody will be administered, followed by PET/CT imaging approximately 0.5 to 1 hour later. Within 1 to 2 weeks, 18F-FDG PET/CT imaging will be performed, which requires an intravenous injection of 18F-FDG (fasting for at least 4 hours is required) followed by PET/CT imaging approximately 1 hour later.

Diagnostic Test: 68Ga-BCMA nanobody PET/CTDiagnostic Test: 18F-FDG PET/CT

Interventions

18F-FDG PET/CTDIAGNOSTIC_TEST

Within 1 to 2 weeks, 18F-FDG PET/CT imaging will be performed, which requires an intravenous injection of 18F-FDG (fasting for at least 4 hours is required) followed by PET/CT imaging approximately 1 hour later.

BCMA and FDG
68Ga-BCMA nanobody PET/CTDIAGNOSTIC_TEST

On the day of the examination (fasting is not required), an intravenous injection of the 68Ga-NOTA-BCMA nanobody will be administered, followed by PET/CT imaging approximately 0.5 to 1 hour later.

BCMA and FDG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed or relapsed MM patients
  • Written informed consent obtained and capable of undergoing follow-up.

You may not qualify if:

  • Severely abnormal liver and kidney function
  • Women who are planning pregnancy, are pregnant, or are breastfeeding, as well as those with childcare plans during the study period; subjects of childbearing potential must use effective contraceptive measures throughout the study.
  • Individuals unable to lie flat for 30 minutes.
  • Individuals who decline to participate in this clinical study.
  • Patients with claustrophobia or other psychiatric disorders, or poor compliance that may compromise their ability to cooperate with the study procedures.
  • Other circumstances deemed by the investigator as unsuitable for participation in this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College

Beijing, 100730, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Yaping Luo

    Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaping Luo

CONTACT

010-69154716luoyaping@live.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2025

First Posted

January 20, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

January 20, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)